Active not recruitingNAINTERVENTIONAL

Childrens Real Food Tolerance Study

This 28-day study is for children aged 1 to 16 who need help meeting their nutritional needs, perhaps due to slow growth or other health issues. We are testing new types of nutritional feeds, including tube feeds and drinks, made with real food ingredients. Many current feeds are highly processed, and some parents prefer to use home-blended foods, though these have risks. This study aims to check how well children tolerate these new, safer, real-food-based options, how easy they are to use, and if they are safe. We'll be looking at two new tube feeds and one new nutritional drink. It's about finding better ways to support children's growth and health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nutricia UK Ltd

Enrolment target

Start

01 May 2022

Estimated completion

31 Dec 2028

Malnutrition, Child

What is this study about?

This study is all about helping children who aren't growing as they should, or who have health conditions that make it hard for them to get enough nutrients from food alone. Usually, doctors prescribe special liquid feeds or drinks to make sure these children get the nutrition they need. While these existing products are good and provide all necessary nutrients, they are often quite processed.

Some parents have started using homemade blended foods through their child's feeding tubes, believing these are more 'natural'. While this can have some benefits, there are also worries. For example, it can be hard to know if the homemade blends have all the right nutrients, if they are completely safe from germs, or if they might block feeding tubes.

Because of these concerns, a company has developed new liquid feeds and drinks that include real food ingredients, but are still sterile (clean from germs), safe, and have a consistent amount of nutrients. These new products are designed for children aged 1 to 16. This study wants to find out if these new real-food-based feeds are well-tolerated by children, if parents find them easy to use, and if they are safe.

Key takeaways

New nutritional feeds with 'real food' ingredients are being studied.
The study is for children aged 1 to 16 who need extra nutritional help.
It aims to check how well children tolerate these new feeds over 28 days.
The feeds are designed to be safe, clean, and contain consistent nutrients.
This could offer a new option for children needing nutritional support.

Who may be eligible?

This study is suitable for children between 1 and 16 years old who currently need extra nutritional support, either through a feeding tube or with special nutritional drinks. They should expect to receive at least 300 calories per day from the study product for at least 28 days. Before joining, a parent or guardian will need to give their informed consent.

However, some children won't be able to take part. This includes children who get all their nutrition directly into their veins (called total parenteral nutrition), or those with allergies to any ingredients in the study products. Children with severe milk sugar (galactose or lactose) intolerance, or serious liver, metabolism, or kidney problems can't join.

Also, children needing special fibre-free or highly broken-down feeds, or those undergoing strong chemotherapy or radiation, or those with certain conditions like pancreatitis or inflammatory bowel disease, won't be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 1 and 16 years old?
Does your child currently need nutritional support through a tube or special drinks?
Does your child *not* have severe allergies to common food ingredients?
Is your child *not* receiving all their nutrition directly into their veins?
Does your child *not* have severe liver, kidney, or metabolic problems?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will try one of the new nutritional feeds (either a tube feed or a drink) for 28 days. During this time, the study team will regularly check how well your child tolerates the feed, if they are gaining enough nutrients, and if there are any side effects. You'll likely need to keep a record or logbook at home, and there will be visits to the clinic for check-ups and measurements. The total duration of active participation in the study for your child will be 28 days, plus initial and final assessments.

Potential risks and benefits

Taking part in this study could offer the benefit of trying a new nutritional feed made with real food ingredients, which might be helpful for your child's growth and well-being. However, as with any new treatment, there's always a chance of side effects or that the feed may not suit your child. The study team will closely monitor your child for any problems, but potential risks are not fully known yet. You are free to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Bristol Royal Hospital for Children
Verified postcode
Bristol, United Kingdom

Common questions

What kind of 'real food' is in these feeds?

The study feeds are based on real food ingredients, but the exact details would be available from the study team. They are designed to be safe and nutritionally complete.

Can my child stop using their usual feeds to join?

The study products are designed to replace some or all of your child's usual nutritional support. The study team will guide you on how this will work.

Will this help my child gain weight?

The feeds are designed to provide essential calories and nutrients. The study aims to see if they can effectively support growth and nutritional needs.

What happens after the 28 days?

After 28 days, your child's participation in the study ends. The study team will discuss next steps for their ongoing nutritional care with you.

Is this feed available everywhere?

These are new products being tested in a study. They are not yet widely available commercially until proven safe and effective.